standardised meddra queries (smqs) · standardised meddra queries (smqs) meddra® trademark is...
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MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The activities of the MedDRA Maintenance and Support Services Organization (MSSO) are overseen by an ICH MedDRA Management Board, which is composed of the six ICH parties (EU, EFPIA, MHLW, JPMA, FDA, PhRMA), the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, the Health Canada, and the WHO (as Observer).
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Disclaimer and Copyright NoticeThis presentation is protected by copyright and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the presentation is acknowledged at all times. In case of any adaption, modification or translation of the presentation, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original presentation. Any impression that the adaption, modification or translation of the original presentation is endorsed or sponsored by the ICH must be avoided. The presentation is provided "as is" without warranty of any kind. In no event shall the ICH or the authors of the original presentation be liable for any claim, damages or other liability arising from the use of the presentation.The above-mentioned permissions do not apply to content supplied by third parties. Therefore, for documents where the copyright vests in a third party, permission for reproduction must be obtained from this copyright holder.
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CIOMS and SMQs• CIOMS (Council for International Organizations of
Medical Sciences): An international, non-governmental, non-profit organization established jointly by World Health Organization (WHO) and United Nations Educational, Scientific and Cultural Organization (UNESCO)
• CIOMS and ICH have established terms of reference for cooperative development of SMQs
• Maintenance of SMQs is the joint responsibility of the user community (through MSSO Change Request process) and the MSSO
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Definition of SMQ• Result of cooperative effort between CIOMS and
ICH (MSSO)• Groupings of terms from one or more MedDRA
System Organ Classes (SOCs) related to defined medical condition or area of interest
• Included terms may relate to signs, symptoms, diagnoses, syndromes, physical findings, laboratory and other physiologic test data, etc., related to medical condition or area of interest
• Intended to aid in case identification
SMQs in Production - Examples• As of Version 15.1, a total of 87 in production
• Agranulocytosis• Anaphylactic reaction• Cerebrovascular
disorders• Convulsions• Depression and
suicide/self-injury• Hepatic disorders• Ischaemic heart disease• Lack of efficacy/effect
• Peripheral neuropathy• Pregnancy and neonatal
topics• Pseudomembranous colitis• Rhabdomyolysis/myopathy• Severe cutaneous adverse
reactions• Systemic lupus
erythematosus
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SMQ Production and Development List
• Refer to MSSO Web site for current status of SMQs in production and development
http://www.meddramsso.com/subscriber_smq.asp
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MedDRA Term Inclusion
• SMQs are constructed at MedDRA PT level
• LLTs that are subordinate to an included PT are also included
Narrow and Broad Searches• “Narrow” scope – specificity (cases highly likely
to be condition of interest) • “Broad” scope – sensitivity (all possible cases)• “Broad search” = All broad + all narrow terms
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Algorithmic SMQs
• Some SMQs are designed to utilize algorithms
• Better case identification among broad search terms may result if cases are selected by a defined combination of selected terms
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Algorithmic SMQ Example• Anaphylactic reaction (SMQ):
– A case with any of the following PTs:• Anaphylactic reaction• Anaphylactic shock• Anaphylactic transfusion reaction• Anaphylactoid reaction• Anaphylactoid shock• Circulatory collapse• First use syndrome• Kounis syndrome• Shock• Type I hypersensitivity
(Narrow search terms = Category A)16
Algorithmic SMQ Example (cont)
• Case = A (Narrow terms) • Or Term from Category B and term from Category C• Or Term from either Category B or Category C plus Term from
Category D
Category B –Upper airway/Respiratory
Category C –Angioedema/Urticaria, etc.
Category D –Cardiovascular/Hypotension
Acute respiratory failure
Allergic oedema Blood pressure decreased
Asthma Angioedema Blood pressure diastolic decreased
Bronchial oedema Erythema Blood pressure systolic decreased
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Hierarchical SMQs• Some SMQs may develop as set of
queries related to one another in a hierarchical relationship
• Not related to MedDRA standard hierarchy
• One or more subordinate SMQs combined to create a superordinate, more inclusive SMQ
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Hierarchical SMQ Example
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Haematopoietic cytopenias
Haematopoietic cytopenias
Haematopoietic cytopenias affecting more than one type
of blood cell
Haematopoietic cytopenias affecting more than one type
of blood cell
Haematopoietic erythropenia
Haematopoietic erythropenia
Haematopoietic leukopeniaHaematopoietic leukopenia
Haematopoietic thrombocytopeniaHaematopoietic
thrombocytopenia
Text Data Included in SMQ• Description field
– Additional information about each SMQ (from SMQ Introductory Guide)
• Source field– Medical references used in development/
maintenance• Development note
– Pertinent notes for proper use– Description of algorithm (if applicable), and
definition of categories20
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SMQ Development Summary
• Pre-release testing by CIOMS Working Group members– Typically, at least one company and one regulator
database– Cases retrieved reviewed for relevance– Fine-tuning of SMQ may require several iterations– Reviewed and approved by CIOMS WG
• Production Phase: continue to be fine-tuned through the MSSO maintenance process
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SMQ Production Maintenance• Essentially a change request process• Final disposition is not time limited• MSSO reviews all new terms in new release for
inclusion in existing SMQs• MSSO reviews existing terms for impact of
demotions, moves, etc.• All SMQ change requests reviewed by CIOMS WG
after 18-24 months in production
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SMQ Production Maintenance (cont)
• SMQ change requests undergo the same process as other MedDRA change requests– SMQ change requests are considered
simple change requests– SMQ change requests are part of the 100
allotted change requests for each core subscriber
SMQ Applications• Clinical trials
– Where safety profile is not fully established, use multiple SMQs on routine basis as screening tool
– Selected SMQs to evaluate previously identified issue (pre-clinical data or class effect)
• Postmarketing– Selected SMQs to retrieve cases for suspected or
known safety issue– Signal detection (multiple SMQs employed)– Single case alerts– Periodic reporting (aggregate cases for safety and
other issues, e.g., lack of efficacy)26
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Summary• Background of SMQ development• SMQ definition• SMQ development status• SMQ data characteristics• SMQ testing and maintenance• SMQ applications
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MSSO Contacts• Web site
• www.meddramsso.com
• Help Desk– Phone
• International AT&T Toll Free: 877.258.8280• Direct Dial (USA): +1 571.313.2574
– E-mail• [email protected]